A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC)

Ulcerative Colitis (UC) Clinical Trial

— U-ACHIEVE  

Official title:

A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects With Ulcerative Colitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03006068
• Other study ID #: M14-533
• Secondary ID: 2016-000674-38
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 31, 2017
• Est. completion date: July 21, 2027

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the long-term safety and efficacy of Upadacitinib in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 Substudy 1, who have had loss of response during the maintenance period of Study M14-234 Substudy 3, or who have successfully completed Study M14-234 Substudy 3.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 950
• Est. completion date: July 21, 2027
• Est. primary completion date: July 21, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

Inclusion Criteria:

Note: Participants aged 16 or 17 may enroll in M14-234 or M14-675 where locally permissible

• Participant has not achieved clinical response at the end of the induction period (Week 8) in Study M14-234 Substudy 1, has had loss of response during the maintenance period of Study M14-234 Substudy 3, or has successfully completed Study M14-234 Substudy 3. During the COVID-19 pandemic, for participants with missing endoscopy at Week 8, Week 16 or Week 52 due to the COVID-19 pandemic in Studies M14-234 Substudy 2, M14-234 Substudy 3 and M14-675, participants may be enrolled if certain criteria are met.

• If female, participant must meet the contraception criteria.

• Women of childbearing potential must have a negative urine pregnancy test at Week 0 visit.

• Participant is judged to be in otherwise good health as determined by the principal investigator based upon clinical evaluations performed during the preceding study (Study M14-234).

• Must be able and willing to give written informed consent and to comply with the requirements of this study protocol.

Exclusion Criteria:

• For any reason participant is considered by the investigator to be an unsuitable candidate.

• Female participant with a positive pregnancy test at the final visit of Study M14-234 or who is considering becoming pregnant during the study or within 30 days after the last dose of study drug.

• Known hypersensitivity to upadacitinib or its excipients or had any adverse event (AE) during the preceding studies, that in the investigator's judgment makes the participant unsuitable for this study.

• Participant with an active or recurrent infection that based on the investigator's clinical assessment makes the participant an unsuitable candidate for the study. Participants with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been successfully treated.

• Current evidence of active tuberculosis (TB); current evidence of latent tuberculosis and for any reason the participant cannot take full course of TB prophylaxis treatment as required per protocol.

• Participant with a poorly controlled medical condition, such as uncontrolled diabetes, unstable ischemic heart disease, moderate or severe congestive heart failure (New York Heart Association class III or IV), recent cerebrovascular accidents and any other condition which, in the opinion of the investigator or sponsor, would put the subject at risk by participation in this study.

• Participants have malignancy, high-grade dysplasia, un-removed low-grade dysplasia of the gastrointestinal tract diagnosed at the endoscopy performed at the final visit of Study M14-234.

• History of any malignancy except for successfully treated nonmelanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix from evaluations performed in Study M14-234.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis (UC)

Intervention

Drug:
• Upadacitinib (ABT-494)
Upadacitinib (ABT-494) will be administered orally.
• Placebo
Placebo will be administered orally.

Locations

Country	Name	City	State
Argentina	Gedyt /ID# 210016	Ciudad Autonoma de Buenos Aire	Ciudad Autonoma De Buenos Aires
Argentina	Hospital Britanico de Buenos Aires /ID# 209496	Ciudad Autonoma de Buenos Aire	Ciudad Autonoma De Buenos Aires
Argentina	Mautalen Salud e Investigacion /ID# 171174	Ciudad Autonoma de Buenos Aire	Ciudad Autonoma De Buenos Aires
Argentina	Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 164186	Cordoba
Argentina	Cardio Alem /ID# 211281	San Isidro	Buenos Aires
Argentina	Sanatorio 9 de Julio /ID# 150215	San Miguel de Tucumán	Tucuman
Australia	Monash Medical Centre /ID# 150218	Clayton	Victoria
Australia	St Vincent's Hospital Melbourne /ID# 152503	Fitzroy Melbourne	Victoria
Australia	Macquarie University Hospital /ID# 211953	Macquarie University	New South Wales
Australia	Fiona Stanley Hospital /ID# 211641	Murdoch	Western Australia
Australia	Mater Misericordiae Limited /ID# 212686	South Brisbane	Queensland
Australia	Griffith University /ID# 211954	Southport	Queensland
Austria	Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 150462	Linz	Oberoesterreich
Austria	Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 150463	Salzburg
Austria	Klinik Landstrasse /ID# 162867	Vienna	Wien
Austria	Medizinische Universitaet Wien /ID# 150616	Vienna	Wien
Belarus	Vitebsk Regional Advanced Clin /ID# 169592	???????
Belgium	AZ Maria Middelares /ID# 150466	Gent
Belgium	Universitair Ziekenhuis Leuven /ID# 150468	Leuven	Vlaams-Brabant
Belgium	AZ-Delta /ID# 150467	Roeselare	West-Vlaanderen
Bosnia and Herzegovina	Duplicate_University Clinical Centre of the Republic of Srpska /ID# 150223	Banja Luka	Republika Srpska
Bosnia and Herzegovina	Duplicate_University Clinical Centre of the Republic of Srpska /ID# 150712	Banja Luka	Republika Srpska
Bosnia and Herzegovina	University Clinical Hospital Mostar /ID# 150711	Mostar
Bosnia and Herzegovina	Clinical Center University of Sarajevo /ID# 150222	Sarajevo
Bosnia and Herzegovina	University Clinical Center Tuzla /ID# 150224	Tuzla	Tuzlanski
Brazil	Upeclin Fmb - Unesp /Id# 152493	Botucatu	Sao Paulo
Brazil	Hospital Nossa Senhora das Graças /ID# 152488	Curitiba	Parana
Brazil	Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 153744	Goiânia	Goias
Brazil	Hospital de Clinicas de Porto Alegre /ID# 153745	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 152492	Ribeirão Preto	Sao Paulo
Brazil	Faculdade de Medicina do ABC /ID# 152489	Santo André	La Spezia
Brazil	Kaiser Clinica e Hospital Dia /ID# 152491	Sao Jose Do Rio Preto	Sao Paulo
Canada	University of Calgary /ID# 151818	Calgary	Alberta
Canada	Allen Whey Khye Lim Professional Corporation /ID# 211169	Edmonton	Alberta
Canada	Covenant Health /ID# 158931	Edmonton	Alberta
Canada	University of Alberta Hospital /ID# 151824	Edmonton	Alberta
Canada	CISSS de la Monteregie /ID# 159271	Greenfield Park	Quebec
Canada	Hamilton Health Sciences - McMaster University Medical Centre /ID# 150477	Hamilton	Ontario
Canada	OCT Research ULC /ID# 153179	Kelowna	British Columbia
Canada	Duplicate_CISSS de Chaudière-Appalaches, Hôpital Hotel-Dieu de Lévis /ID# 150473	Levis	Quebec
Canada	Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 167170	Montreal	Quebec
Canada	Recherche GCP Research /ID# 151819	Montreal	Quebec
Canada	Montreal General Hospital - McGill University Health Centre /ID# 170013	Montréal	Quebec
Canada	Ottawa Hospital Research Institute /ID# 151817	Ottawa	Ontario
Canada	CIUSSS de l'Estrie - CHUS /ID# 150478	Sherbrooke	Quebec
Canada	Medicor Research Inc /ID# 151825	Sudbury	Ontario
Canada	Toronto Digestive Disease Associates, Inc. /ID# 150475	Vaughan	Ontario
Canada	Percuro Clinical Research, Ltd /ID# 150479	Victoria	British Columbia
Chile	Hospital Guillermo Grant Benavente de Concepción /ID# 212425	Concepción
Chile	CTR Estudios Clinicos /ID# 200111	Providencia
Chile	Hospital Clinico Universidad De Los Andes /ID# 207427	Santiago
Chile	M y F Estudios Clínicos /ID# 200112	Santiago	Region Metropolitana Santiago
Chile	Research Group /ID# 203177	Santiago	Region Metropolitana De Santiago
Chile	Centro de Investigaciones Clínicas Viña del Mar /ID# 150226	Viña del Mar	Valparaíso
China	The First Hospital of Jilin University /ID# 210087	Changchun	Jilin
China	Xiangya Hospital Central South University /ID# 167230	Changsha	Hunan
China	West China Hospital, Sichuan University /ID# 167041	Chengdu	Sichuan
China	The First Affiliated Hospital, Sun Yat-sen University /ID# 150517	Guangzhou	Guangdong
China	The Sixth Affiliated Hosp Sun /ID# 150518	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 150516	Hangzhou	Zhejiang
China	The second affiliated hospital of Zhejiang University school of medicine /ID# 165813	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Nanchang University /ID# 212185	Nanchang	Jiangxi
China	Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 165826	Shanghai	Shanghai
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 150523	Shanghai	Shanghai
China	Shanghai Tenth People's Hospital /ID# 150522	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University /ID# 166921	Shenyang	Liaoning
China	Affiliated Taihe Hospital of Hubei University of Medicine /ID# 216407	Shiyan	Hubei
China	Tianjin Medical University General Hospital /ID# 170605	Tianjin
China	Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 167089	Wuhan	Hubei
China	Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167079	Wuhan	Hubei
Colombia	Coorp Hosp Juan Ciudad Sede Hospital Universitario Mayor Mederi /ID# 152811	Bogota DC	Cundinamarca
Colombia	Hospital Universitario de San /ID# 155388	Medellin
Colombia	Oncomedica SAS /ID# 207052	Monteria	Cordoba
Croatia	Poliklinika Solmed /ID# 211567	Grad Zagreb
Croatia	Duplicate_Klinicki bolnicki centar Osijek /ID# 150229	Osijek	Osjecko-baranjska Zupanija
Croatia	Klinicki bolnicki centar Rijeka /ID# 150714	Rijeka	Primorsko-goranska Zupanija
Croatia	Klinicki Bolnicki Centar (KBC) Split /ID# 213989	Split	Splitsko-dalmatinska Zupanija
Croatia	Zadar General Hospital /ID# 150261	Zadar
Croatia	Klinicka bolnica Dubrava Zagreb /ID# 150228	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Zagreb /ID# 150262	Zagreb	Grad Zagreb
Croatia	Klinicki bolnicki centar Zagreb /ID# 150715	Zagreb	Grad Zagreb
Czechia	Hepato-Gastroenterologie HK, s.r.o. /ID# 150946	Hradec Kralove
Czechia	CTCenter MaVe s.r.o. /ID# 150903	Olomouc
Czechia	ARTROSCAN s.r.o. /ID# 150502	Ostrava
Czechia	Nemocnice Pardubickeho kraje, a.s. /ID# 213541	Pardubice
Czechia	Iscare Klinické Centrum /ID# 209279	Prague	Praha 9
Czechia	Axon Clinical, s.r.o. /ID# 152477	Praha
Czechia	Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 216224	Praha
Estonia	North Estonia Medical Centre /ID# 160871	Mustamäe Linnaosa	Harjumaa
Estonia	East Tallinn Central Hospital - Magdaleena Unit /ID# 150488	Tallinn	Harjumaa
Estonia	West Tallinn Central Hospital /ID# 150490	Tallinn
Estonia	Tartu University Hospital /ID# 150489	Tartu Linn	Tartumaa
Finland	Duplicate_Helsinki Univ Central Hospital /ID# 154283	Helsinki
Finland	Keski-Suomen Sairaala Nova /ID# 155665	Jyvaskyla
Finland	Laakarikeskus Ikioma /ID# 150377	Mikkeli
Finland	Tampereen yliopistollinen sairaala /ID# 150376	Tampere	Pirkanmaa
Finland	Tyks Kantasairaalan Alue /ID# 169895	Turku	Varsinais-Suomi
France	CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 165749	La Roche Sur Yon	Vendee
France	CHRU Lille - Hopital Claude Huriez /ID# 152609	Lille	Nord
France	CHU Montpellier - Hopital Saint Eloi /ID# 200088	Montpellier Cedex 5	Herault
France	Chu de Nice-Hopital Larchet Ii /Id# 152608	Nice	Alpes-Maritimes
France	HCL - Hopital Lyon Sud /ID# 152540	Pierre Benite CEDEX	Rhone
France	CHU de Saint-Etienne, Hopital Nord /ID# 165756	SAINT-ETIENNE Cedex 1
Germany	MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 151697	Berlin
Germany	Duplicate_Agaplesion Markus Krankenhaus /ID# 161870	Frankfurt am Main	Hessen
Germany	Gastroenterologische Gemeinschaftspraxis Herne /ID# 214575	Herne	Nordrhein-Westfalen
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 161871	Kiel	Schleswig-Holstein
Germany	Universitatsklinikum Mannheim /ID# 150405	Mannheim	Baden-Wuerttemberg
Germany	Medizinisches Versorgungszentrum Portal 10 /ID# 207136	Muenster
Germany	Duplicate_Universitaetsklinikum Muenster /ID# 150402	Munster	Niedersachsen
Germany	Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 215812	Saarbrücken	Saarland
Germany	Universitätsklinikum Tübingen /ID# 151698	Tübingen	Baden-Wuerttemberg
Germany	Praxis medicum /ID# 150404	Wiesbaden
Greece	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 150406	Athens
Greece	General Hospital of Athens Laiko /ID# 208672	Athens	Attiki
Greece	General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202101	Athens	Attiki
Greece	University General Hospital of Heraklion PA.G.N.I /ID# 150236	Heraklion	Kriti
Greece	University General Hospital of Ioannina /ID# 164247	Ioannina
Greece	General Hospital of Thessaloniki Hippokrateio /ID# 209522	Thessaloniki
Greece	Theageneio Anticancer Hospital /ID# 164187	Thessaloniki
Hungary	Bekes Megyei Kozponti Korhaz /ID# 151601	Bekescsaba
Hungary	Semmelweis Egyetem /ID# 150409	Budapest
Hungary	Meditres Kft. /ID# 151597	Kecskemet
Hungary	Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 151599	Sopron
Hungary	Mentahaz Maganorvosi Kozpont /ID# 206977	Szekesfehervar
Hungary	Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 150410	Szombathely	Vas
Ireland	Mercy University Hospital /ID# 153794	Cork
Ireland	Beaumont Hospital /ID# 150414	Dublin
Ireland	St James Hospital /ID# 150413	Dublin 8	Dublin
Ireland	St Vincent's University Hospital /ID# 150411	Elm Park	Dublin
Ireland	University Hospital Galway /ID# 150412	Galway
Israel	Soroka University Medical Center /ID# 156562	Be'er Sheva	HaDarom
Israel	Rambam Health Care Campus /ID# 150416	Haifa	H_efa
Israel	Hadassah Medical Center-Hebrew University /ID# 165119	Jerusalem	Yerushalayim
Israel	Shaare Zedek Medical Center /ID# 163139	Jerusalem	Yerushalayim
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 150424	Bologna
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 150421	Milan
Italy	ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 150605	Milano
Italy	IRCCS Ospedale Sacro Cuore Don Calabria /ID# 201726	Negrar	Verona
Italy	A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 150263	Palermo
Italy	ASST Rhodense/Presidio Ospedaliero di Rho /ID# 216673	Rho	Milano
Italy	Azienda Ospedaliera San Camillo Forlanini /ID# 151362	Rome	Roma
Italy	Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 150425	Rome	Roma
Italy	Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 150420	Rome	Roma
Italy	Istituto Clinico Humanitas /ID# 151363	Rozzano	Milano
Japan	Tokatsu Tsujinaka Hospital /ID# 214964	Abiko-shi	Chiba
Japan	Asahikawa Medical University Hospital /ID# 170281	Asahikawa-shi	Hokkaido
Japan	Tokyo Medical And Dental University Hospital /ID# 152017	Bunkyo-ku	Tokyo
Japan	Fukuoka University Chikushi Hospital /ID# 152627	Chikushino-shi	Fukuoka
Japan	St.Luke's International Hospital /ID# 208075	Chuo-ku	Tokyo
Japan	Fukui Prefectural Hospital /ID# 210450	Fukui-shi	Fukui
Japan	Kyushu University Hospital /ID# 152525	Fukuoka-shi	Fukuoka
Japan	Saiseikai Fukuoka Genaral Hospital /ID# 209481	Fukuoka-shi	Fukuoka
Japan	NHO Fukuyama Medical Center /ID# 206294	Fukuyama-shi	Hiroshima
Japan	Tokai University Hachioji Hospital /ID# 152584	Hachioji-shi	Tokyo
Japan	Hamamatsu University Hospital /ID# 205709	Hamamatsu-shi	Shizuoka
Japan	National Hospital Organization Mito Medical Center /ID# 152626	Higashi Ibaraki-gun	Ibaraki
Japan	National Hospital Organization Higashi-Ohmi General Medical Center /ID# 210711	Higashi-ohmi-shi	Shiga
Japan	National Hospital Organization Hirosaki General Medical Center /ID# 152761	Hirosaki-shi	Aomori
Japan	Hiroshima University Hospital /ID# 151952	Hiroshima-shi	Hiroshima
Japan	Shimane University Hospital /ID# 208906	Izumo-shi	Shimane
Japan	Idzuro Imamura Hospital /ID# 207640	Kagoshima-shi	Kagoshima
Japan	Imamura General Hospital /ID# 227138	Kagoshima-shi	Kagoshima
Japan	Kagoshima IBD Gastroenterology Clinic /ID# 245222	Kagoshima-shi	Kagoshima
Japan	Sameshima Hospital /ID# 206673	Kagoshima-shi	Kagoshima
Japan	Kanazawa University Hospital /ID# 207810	Kanazawa-shi	Ishikawa
Japan	Tsujinaka Hospital Kashiwanoha /ID# 209572	Kashiwa-shi	Chiba
Japan	Saitama Medical Center /ID# 152019	Kawagoe-shi	Saitama
Japan	St. Marianna University Hospital /ID# 209452	Kawasaki-shi	Kanagawa
Japan	Duplicate_Kitakyushu Municipal Medical Center /ID# 152589	Kitakyushu	Fukuoka
Japan	Aoyama Clinic /ID# 152048	Kobe-shi	Hyogo
Japan	Yamanashi Prefectural Central Hospital /ID# 151909	Kofu-shi	Yamanashi
Japan	Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 157820	Kurashiki-shi	Okayama
Japan	Kurume University Hospital /ID# 151977	Kurume-shi	Fukuoka
Japan	Japanese Red Cross Kyoto Daiichi Hosital /ID# 152358	Kyoto-shi	Kyoto
Japan	Kyoto University Hospital /ID# 211808	Kyoto-shi	Kyoto
Japan	Kitasato University Kitasato Institute Hospital /ID# 152687	Minato-ku	Tokyo
Japan	Kyorin University - Mitaka Campus /ID# 153195	Mitaka
Japan	Iwate Medical University Uchimaru Medical Center /ID# 203412	Morioka-shi	Iwate
Japan	Aichi Medical University /ID# 151994	Nagakute	Aichi
Japan	Nagoya City University Hospital /ID# 151949	Nagoya shi	Aichi
Japan	Nagoya University Hospital /ID# 152728	Nagoya-shi	Aichi
Japan	Niigata University Medical & Dental Hospital /ID# 218050	Niigata-shi	Niigata
Japan	Saiseikai Niigata Hospital /ID# 209923	Niigata-shi	Niigata
Japan	Hyogo Medical University Hospital /ID# 152433	Nishinomiya-shi	Hyogo
Japan	Obihiro kosei Hospital /ID# 210425	Obihiro-shi	Hokkaido
Japan	Ogaki Municipal Hospital /ID# 208226	Ogaki-shi	Gifu
Japan	Ishida Clinic of IBD and Gastroenterology /ID# 210118	Oita-shi	Oita
Japan	Duplicate_Okayama University Hospital /ID# 217924	Okayama-shi	Okayama
Japan	NHO Nagasaki Medical Center /ID# 210821	Omura-shi	Nagasaki
Japan	Japanese Red Cross Osaka Hospital /ID# 209477	Osaka-shi	Osaka
Japan	Kinshukai Infusion Clinic /ID# 207866	Osaka-shi	Osaka
Japan	Kitano Hospital, Tazuke Kofukai Medical Research Institute /ID# 210396	Osaka-shi	Osaka
Japan	Osaka City General Hospital /ID# 152703	Osaka-shi	Osaka
Japan	Osaka Metropolitan University Hospital /ID# 152681	Osaka-shi	Osaka
Japan	Saga University Hospital /ID# 209272	Saga-shi	Saga
Japan	Tokitokai Tokito clinic /ID# 152676	Saitama-shi	Saitama
Japan	Toho University Sakura Medical Center /ID# 151935	Sakura-shi	Chiba
Japan	Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 151705	Sapporo-shi	Hokkaido
Japan	Sapporo Higashi Tokushukai Hospital /ID# 208495	Sapporo-shi	Hokkaido
Japan	Sapporo Medical University Hospital /ID# 206493	Sapporo-shi	Hokkaido
Japan	Sapporo Tokushukai Hospital /ID# 209449	Sapporo-shi	Hokkaido
Japan	National Hospital Organization Sendai Medical Center /ID# 209529	Sendai-shi	Miyagi
Japan	Center hospital of the National Center for Global Health and Medicine /ID# 209533	Shinjuku-ku	Tokyo
Japan	Tokyo Women's Medical University Hospital /ID# 205978	Shinjuku-ku	Tokyo
Japan	Tokuyama Central Hospital /ID# 216995	Shunan-shi	Yamaguchi
Japan	NHO Shizuoka Medical Center /ID# 163571	Sunto-gun	Shizuoka
Japan	Shoyukai Fujita Gastroenterological Hospital /ID# 216494	Takatsuki-shi
Japan	Teikyo University /ID# 209865	Tokyo
Japan	Toyohashi Municipal Hospital /ID# 171470	Toyohashi-shi	Aichi
Japan	Toyonaka Municipal Hospital /ID# 217083	Toyonaka-shi	Osaka
Japan	Ieda Hospital /ID# 157782	Toyota-shi	Aichi
Japan	Mie University Hospital /ID# 207253	Tsu-shi	Mie
Japan	Juntendo University Urayasu Hospital /ID# 208783	Urayasu-shi	Chiba
Japan	Yamagata University Hospital /ID# 171468	Yamagata-shi	Yamagata
Japan	Kenseikai Dongo Hospital /ID# 208102	Yamatotakada-shi	Nara
Japan	Yokkaichi Hazu Medical Center /ID# 214349	Yokkaichi-shi	Mie
Japan	Yokohama City University Medical Center /ID# 169900	Yokohama shi	Kanagawa
Japan	Showa University Fujigaoka Hospital /ID# 208223	Yokohama-shi	Kanagawa
Korea, Republic of	Dong-A University Medical Center /ID# 161568	Busan	Gyeongsangnamdo
Korea, Republic of	Pusan National University Hospital /ID# 161569	Busan
Korea, Republic of	Yeungnam University Medical Center /ID# 150432	Daegu
Korea, Republic of	Duplicate_Hanyang University Gurihospital /ID# 150431	Guri	Gyeonggido
Korea, Republic of	Duplicate_CHA University Bundang Medical Center /ID# 161567	Seongnam	Gyeonggido
Korea, Republic of	Asan Medical Center /ID# 159155	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Kangbuk Samsung Hospital /ID# 150435	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center /ID# 150433	Seoul
Korea, Republic of	Yonsei University Health System Severance Hospital /ID# 161566	Seoul	Seoul Teugbyeolsi
Korea, Republic of	The Catholic University Of Korea St. Vincent's Hospital /ID# 150434	Suwon	Gyeonggido
Latvia	Pauls Stradins Clinical University Hospital /ID# 153183	Riga	Riga
Latvia	VCA Polyclinic Aura /ID# 150436	Riga
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 150439	Kaunas
Lithuania	Klaipeda university hospital /ID# 163501	Klaipeda
Lithuania	Klaipeda University Hospital /ID# 163719	Klaipeda
Lithuania	Vilnius University Hospital /ID# 164172	Vilnius
Malaysia	Hospital Sultanah Bahiyah /ID# 152310	Alor Setar	Kedah
Malaysia	Hospital Ampang /ID# 152311	Ampang
Malaysia	Uni Malaya MC /ID# 150440	Kuala Lumpur
Malaysia	Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 152313	Kuala Lumpur	Selangor
Mexico	Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 202334	Guadalajara	Jalisco
Mexico	Morales Vargas Centro de Investigacion S.C. /ID# 211327	Leon	Guanajuato
Mexico	Centro Regiomontano de Estudios Clínicos ROMA S.C /ID# 150265	Monterrey	Nuevo Leon
Netherlands	Amsterdam UMC, locatie AMC /ID# 150617	Amsterdam	Noord-Holland
Netherlands	Leids Universitair Medisch Centrum /ID# 152625	Leiden
Netherlands	Radboud Universitair Medisch Centrum /ID# 151701	Nijmegen	Gelderland
Netherlands	Duplicate_Erasmus Medisch Centrum /ID# 150619	Rotterdam	Zuid-Holland
Netherlands	Universitair Medisch Centrum Utrecht /ID# 152776	Utrecht
Norway	Akershus Universitetssykehus_MAIN /ID# 150622	Lorenskog	Akershus
Norway	Universitetssykehuset I Nord-Norge /ID# 152836	Tromsø	Troms
Poland	Endoskopia Sp. z o.o. /ID# 152940	Sopot	Pomorskie
Poland	Gastromed Sp. z o.o /ID# 216198	Torun	Kujawsko-pomorskie
Poland	Centrum Medyczne Reuma Park /ID# 150624	Warszawa	Mazowieckie
Poland	Centrum Zdrowia MDM /ID# 150626	Warszawa	Mazowieckie
Poland	Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 215733	Warszawa	Mazowieckie
Poland	NZOZ Vivamed Jadwiga Miecz /ID# 216743	Warszawa	Mazowieckie
Poland	Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 150627	Warszawa	Mazowieckie
Portugal	Duplicate_Hospital Garcia de Orta, EPE /ID# 151622	Almada	Setubal
Portugal	2CA-Braga, Hospital de Braga /ID# 151617	Braga
Portugal	Duplicate_Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 151616	Guimaraes	Braga
Portugal	Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 151615	Lisboa
Portugal	Duplicate_Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Cap /ID# 151620	Lisboa
Portugal	Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 151618	Ponte de Lima	Viana Do Castelo
Portugal	Centro Hospitalar Universitario de Sao Joao, EPE /ID# 151619	Porto
Portugal	Centro Hospitalar de Entre Douro e Vouga /ID# 152336	Santa Maria Da Feira	Porto
Puerto Rico	School of Medicine University of Puerto Rico-Medical Science Campus /ID# 150629	San Juan
Russian Federation	Immanuel Kant Baltic Federal University /ID# 202129	Kaliningrad	Kaliningradskaya Oblast
Russian Federation	Kazan State Medical University /ID# 166040	Kazan	Tatarstan, Respublika
Russian Federation	Olla-Med Clinic /ID# 215334	Moscow
Russian Federation	Perm Clinical Center of the Federal Medical and Biological Agency /ID# 150634	Perm	Permskiy Kray
Russian Federation	Republican hospital named after V.A. Baranov /ID# 206508	Petrozavodsk
Russian Federation	Euromedservice /ID# 208968	Pushkin
Russian Federation	LLC Novaya Klinika /ID# 208106	Pyatigorsk	Stavropol Skiy Kray
Russian Federation	Medical Company Hepatolog /ID# 200208	Samara	Samarskaya Oblast
Russian Federation	NW State Medical Univ na Mechn /ID# 169332	St. Petersburg	Leningradskaya Oblast
Russian Federation	Duplicate_Stavropol State Medical Univ /ID# 150635	Stavropol
Serbia	Clin Hosp Ctr Bezanijska Kosa /ID# 150640	Belgrade	Beograd
Serbia	Clinical Hosp Center Zvezdara /ID# 150641	Belgrade	Beograd
Serbia	Military Medical Academy /ID# 150643	Belgrade	Beograd
Serbia	University Clinical Center Serbia /ID# 150642	Belgrade	Beograd
Serbia	University Clinical Center Kragujevac /ID# 150644	Kragujevac
Serbia	General Hospital Leskovac /ID# 217882	Leskovac
Serbia	Duplicate_University Clinical Center of Nis /ID# 151902	NIS	Nisavski Okrug
Serbia	University Clinical Center Vojvodina /ID# 150759	Novi Sad
Singapore	Gleneagles Medical Centre /ID# 206020	Singapore
Singapore	National University Hospital /ID# 150583	Singapore
Singapore	Tan Tock Seng Hospital /ID# 150646	Singapore
Slovakia	Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 150869	Banska Bystrica
Slovakia	Medak s.r.o. /ID# 150550	Bratislava
Slovakia	Slovak Research Center Team Me /ID# 150240	Ilava
Slovakia	B+B MED, s.r.o. /ID# 150584	Kosice
Slovakia	Fakultna nemocnica s poliklinikou Nove Zamky /ID# 211371	Nove Zamky
Slovakia	Gastro I., s.r.o. /ID# 150585	Prešov	Presovsky Kraj
South Africa	MD Search /ID# 157524	Boksburg North	Gauteng
South Africa	Kingsbury Hospital /ID# 150587	Cape Town	Western Cape
South Africa	Private Practice Dr MN Rajabally /ID# 155145	Cape Town	Western Cape
South Africa	Spoke Research Inc /ID# 162203	CAPE TOWN Milnerton	Western Cape
South Africa	Clinresco Centers /ID# 163625	Johannesburg	Gauteng
South Africa	Lenasia Clinical Trial Centre /ID# 214361	Johannesburg	Gauteng
South Africa	Wits Clinical Research , Wits Health Consortium (PTY) Ltd /ID# 157730	Johannesburg	Gauteng
South Africa	Wits Clinical Research /ID# 150586	Johannesburg	Gauteng
Spain	Complejo Hospitalario Universitario A Coruña /ID# 203912	A Coruña	A Coruna
Spain	Hospital Clinic de Barcelona /ID# 150598	Barcelona
Spain	Duplicate_Hospital Universitario Reina Sofia /ID# 154031	Cordoba
Spain	Hospital Universitario Dr. Negrin /ID# 203965	Las Palmas de Gran Canaria	Las Palmas
Spain	Hospital Universitario La Paz /ID# 214541	Madrid
Spain	Hospital Universitario Ramon y Cajal /ID# 171491	Madrid
Spain	Hospital Universitario de Salamanca /ID# 150590	Salamanca
Spain	Hospital Universitario Marques de Valdecilla /ID# 216621	Santander	Cantabria
Spain	Hospital Clínico Universitario de Santiago-CHUS /ID# 171492	Santiago de Compostela	A Coruna
Spain	Hospital Universitario y Politecnico La Fe /ID# 150591	Valencia
Sweden	Duplicate_Sahlgrenska University Hospital /ID# 152326	Gothenburg	Vastra Gotalands Lan
Switzerland	Universitätsspital Basel /ID# 161732	Basel Town	Basel-Stadt
Switzerland	Inselspital, Universitaetsspital Bern /ID# 152602	Bern
Switzerland	Kantonsspital St. Gallen /ID# 152601	St. Gallen	Sankt Gallen
Switzerland	University Hospital Zurich /ID# 152603	Zurich	Zuerich
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 150606	Kaohsiung
Taiwan	China Medical University Hospital /ID# 150600	Taichung
Taiwan	Chung Shan Medical University Hospital /ID# 150603	Taichung
Taiwan	National Cheng Kung University Hospital /ID# 151751	Tainan
Taiwan	Taipei Veterans General Hosp /ID# 151750	Taipei
Taiwan	National Taiwan University Hospital /ID# 150604	Taipei City	Taipei
Turkey	Istanbul University Cerrahpasa Faculty of Medicine /ID# 150491	Cerrahpasa
Turkey	Marmara University Medical Fac /ID# 214573	Istanbul
Turkey	Umraniye Training and Res Hosp /ID# 163136	Istanbul
Turkey	Duplicate_Erciyes University Medical Fac /ID# 150495	Melikgazi	Kayseri
Turkey	Mersin University Medical /ID# 163135	Mersin
Turkey	Gazi Universitesi Tip Fakultes /ID# 150493	Yenimahalle	Ankara
Ukraine	Municipal Enterprise "I.I. Mechnikov Dnipropetrovsk Regional Clinical Hospital" /ID# 207731	Dnipro
Ukraine	CNCE of Kharkiv Regional Council Regional Clinical Hospital /ID# 206941	Kharkiv
Ukraine	PE PMC Acinus, Medical and Diagnostic Center /ID# 217219	Kropyvnytskyi
Ukraine	CNPE of Kyiv Regional Council Kyiv Regional Hospital /ID# 217374	Kyiv
Ukraine	Kyiv City Clinical Hospital No.18 /ID# 150505	Kyiv
Ukraine	Medical Center of LLC "Medical Center "Consilium Medical" /ID# 217448	Kyiv
Ukraine	Lviv Regional Clinical Hospital /ID# 150508	Lviv
Ukraine	Municipal Non-Commercial Enterprise Odesa Regional Clinical Hospital of the Od /ID# 162502	Odesa
Ukraine	CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 216302	Vinnytsia	Vinnytska Oblast
Ukraine	Medical Center of the “Health /ID# 162501	Vinnytsya	Vinnytska Oblast
United Kingdom	Hampshire Hospitals NHS Foundation Trust /ID# 150511	Basingstoke	Essex
United Kingdom	Royal United Hospitals Bath /ID# 154211	Bath
United Kingdom	University Hospitals Birmingham NHS Foundation Trust /ID# 150513	Birmingham
United Kingdom	Royal Devon & Exeter Hospital /ID# 150510	Exeter	Devon
United Kingdom	NHS Greater Glasgow and Clyde /ID# 163788	Glasgow	Scotland
United Kingdom	Calderdale and Huddersfield NHS Foundation Trust /ID# 217659	Huddersfield
United Kingdom	Barts Health NHS Trust /ID# 150515	London	London, City Of
United Kingdom	St George's University Hospitals NHS Foundation Trust /ID# 208376	Tooting
United States	Duplicate_University of New Mexico Department of Internal Medicine /ID# 214399	Albuquerque	New Mexico
United States	Huron Gastroenterology Assoc /ID# 152712	Ann Arbor	Michigan
United States	University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 151158	Ann Arbor	Michigan
United States	TX Clinical Research Institute /ID# 151528	Arlington	Texas
United States	Digestive Health Partners - Biltmore Office /ID# 167238	Asheville	North Carolina
United States	University of Maryland Medical Center /ID# 150529	Baltimore	Maryland
United States	Inquest Clinical Research /ID# 164636	Baytown	Texas
United States	Texas Digestive Disease Consultants, PLLC dba GI Alliance /ID# 163630	Bellevue	Washington
United States	Massachusetts General Hospital /ID# 165678	Boston	Massachusetts
United States	HP Clinical Research /ID# 163941	Bountiful	Utah
United States	Advantage Clinical Trials /ID# 163940	Bronx	New York
United States	Montefiore Medical Center - Moses Campus /ID# 150559	Bronx	New York
United States	NY Scientific /ID# 152708	Brooklyn	New York
United States	GI Alliance /ID# 209806	Cedar Park	Texas
United States	Texas Digestive Disease Consultants /ID# 209949	Cedar Park	Texas
United States	Delsol Research Management, Ll /Id# 170130	Chandler	Arizona
United States	Pharmacorp Clinical Trials /ID# 153363	Charleston	South Carolina
United States	Atrium Health Carolinas Medical Center /ID# 157060	Charlotte	North Carolina
United States	Charlotte Gastroenterology and Hepatology, PLLC /ID# 150561	Charlotte	North Carolina
United States	Clin Res Inst of Michigan, LLC /ID# 153031	Chesterfield	Michigan
United States	Clin Res Inst of Michigan, LLC /ID# 161983	Chesterfield	Michigan
United States	Next Innovative Clinical Research - Chicago /ID# 217323	Chicago	Illinois
United States	The University of Chicago DCAM /ID# 150564	Chicago	Illinois
United States	Gastro Health Research /ID# 151683	Cincinnati	Ohio
United States	University of Cincinnati /ID# 164584	Cincinnati	Ohio
United States	West Central Gastroenterology /ID# 155242	Clearwater	Florida
United States	Delta Waves, Inc. /ID# 151727	Colorado Springs	Colorado
United States	Gastro Center of Maryland /ID# 200024	Columbia	Maryland
United States	Optimed Research, Ltd. /ID# 169697	Columbus	Ohio
United States	The Ohio State University /ID# 169417	Columbus	Ohio
United States	Gastro One /ID# 151154	Cordova	Tennessee
United States	Citrus Valley Gastroenterology /ID# 151915	Covina	California
United States	Tri-State Gastroenterology /ID# 169812	Crestview Hills	Kentucky
United States	Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 200771	Dallas	Texas
United States	Duplicate_Western Connecticut Medical Group /ID# 169211	Danbury	Connecticut
United States	Hometown Urgent Care and Resea /ID# 200066	Dayton	Ohio
United States	Moonshine Research Center, Inc /ID# 152534	Doral	Florida
United States	Universal Axon Clinical Research /ID# 213463	Doral	Florida
United States	Cooper Gastroenterology at Fire Road /ID# 153048	Egg Harbor Township	New Jersey
United States	Dayton Gastroenterology, Inc. /ID# 167632	Englewood	Ohio
United States	NorthShore University HealthSystem /ID# 150570	Evanston	Illinois
United States	MediSphere Medical Research Center /ID# 152080	Evansville	Indiana
United States	Plains Clinical Research Center, LLC /ID# 170291	Fargo	North Dakota
United States	Ctr for Gastrointestinal Healt /ID# 153369	Franklin	Virginia
United States	Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 151221	Garland	Texas
United States	Aurora Medical Center - Grafto /ID# 151726	Grafton	Wisconsin
United States	NYU Langone Long Island Clinical Research Association /ID# 155271	Great Neck	New York
United States	Atlantic Gastroenterology Clinical Research /ID# 151901	Greenville	North Carolina
United States	Gastroenterology Associates, P.A. of Greenville /ID# 150557	Greenville	South Carolina
United States	Gastroenterology Center of Connecticut /ID# 150534	Hamden	Connecticut
United States	Palmetto Research, LLC /ID# 151724	Hialeah	Florida
United States	Northwest Health Care Associates /ID# 151591	Hoffman Estates	Illinois
United States	Houma Digestive Health Special /ID# 151851	Houma	Louisiana
United States	Centex Studies, Inc. - Houston /ID# 201217	Houston	Texas
United States	CliniCore International, LLC /ID# 152078	Houston	Texas
United States	Duplicate_Baylor College of Medicine - Baylor Medical Center /ID# 150538	Houston	Texas
United States	GI Specialists of Houston /ID# 202337	Houston	Texas
United States	Vilo Research Group Inc /ID# 212626	Houston	Texas
United States	Newport Huntington Medical Group /ID# 217006	Huntington Beach	California
United States	Indianapolis Gastroenterology /ID# 162914	Indianapolis	Indiana
United States	Nature Coast Clinical Research - Inverness /ID# 154070	Inverness	Florida
United States	University of Iowa Hospitals and Clinics /ID# 157059	Iowa City	Iowa
United States	Southern Therapy and Advanced Research (STAR) LLC /ID# 170713	Jackson	Mississippi
United States	University of Mississippi Medical Center /ID# 213140	Jackson	Mississippi
United States	Encore Borland-Groover Clinical Research /Id# 170913	Jacksonville	Florida
United States	East Tennessee Research Institute /ID# 203611	Johnson City	Tennessee
United States	SIH Research Mumtaz, Inc /ID# 163199	Kissimmee	Florida
United States	UC San Diego Health System /ID# 155187	La Jolla	California
United States	Las Vegas Medical Research /ID# 153052	Las Vegas	Nevada
United States	Dartmouth-Hitchcock Medical Center /ID# 150566	Lebanon	New Hampshire
United States	South Denver Gastroenterology /ID# 151224	Lone Tree	Colorado
United States	United Medical Doctors /ID# 207467	Los Alamitos	California
United States	Gastrointestinal Biosciences Clinical Trials, LLC /ID# 157082	Los Angeles	California
United States	TLC Clinical Research Inc /ID# 216830	Los Angeles	California
United States	Duplicate_Caprock Gastro Research, LLC /ID# 215116	Lubbock	Texas
United States	Gastroenterology Associates of Central Georgia, LLC /ID# 165783	Macon	Georgia
United States	Cfagi Llc /Id# 202018	Maitland	Florida
United States	Great Lakes Gastroenterology Research, LLC /ID# 201773	Mentor	Ohio
United States	Ohio Clinical Research Partner /ID# 154074	Mentor	Ohio
United States	Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211886	Mesa	Arizona
United States	Advanced Pharma CR, LLC /ID# 151723	Miami	Florida
United States	Coral Research Clinic /ID# 150524	Miami	Florida
United States	Crystal Pharmacology Research /ID# 151848	Miami	Florida
United States	New Horizon Research Center /ID# 152475	Miami	Florida
United States	University of Miami /ID# 215443	Miami	Florida
United States	Duplicate_Medical College of Wisconsin /ID# 151850	Milwaukee	Wisconsin
United States	Wisconsin Center for Advanced Research /ID# 151845	Milwaukee	Wisconsin
United States	Facey Medical Foundation /ID# 203135	Mission Hills	California
United States	CB Flock Research Corporation /ID# 165986	Mobile	Alabama
United States	East View Medical Research, LLC /ID# 171184	Mobile	Alabama
United States	Atlantic Digestive Health Inst /ID# 150527	Morristown	New Jersey
United States	United Medical Doctors - Murrieta /ID# 151213	Murrieta	California
United States	Quality Medical Research /ID# 203427	Nashville	Tennessee
United States	Vanderbilt University Medical Center /ID# 153364	Nashville	Tennessee
United States	Rutgers Robert Wood Johnson /ID# 155247	New Brunswick	New Jersey
United States	Nola Research Works, LLC /ID# 153365	New Orleans	Louisiana
United States	Advanced Research Institute, Inc /ID# 163093	New Port Richey	Florida
United States	Columbia Univ Medical Center /ID# 163409	New York	New York
United States	DiGiovanna Institute for Medical Education & Research /ID# 201534	North Massapequa	New York
United States	Advanced Research Institute /ID# 162640	Ogden	Utah
United States	Digestive Disease Specialists /ID# 201057	Oklahoma City	Oklahoma
United States	Hightower Clinical /ID# 216338	Oklahoma City	Oklahoma
United States	Endoscopic Research, Inc. /ID# 151725	Orlando	Florida
United States	Omega Research Group /ID# 200271	Orlando	Florida
United States	Ventura County Gastroenterology Medical Group /ID# 163417	Oxnard	California
United States	Northwest Gastroenterology Clinic /ID# 152528	Portland	Oregon
United States	Premier Medical Group - GI Division /ID# 153366	Poughkeepsie	New York
United States	Inland Empire Clinical Trials, LLC /ID# 216163	Rialto	California
United States	Infinite Clinical Trials /ID# 215342	Riverdale	Georgia
United States	Gastoenterology Group of Rochester /ID# 151080	Rochester	New York
United States	Mayo Clinic - Rochester /ID# 151681	Rochester	Minnesota
United States	Washington University-School of Medicine /ID# 150537	Saint Louis	Missouri
United States	Minnesota Gastroenterology PA /ID# 151682	Saint Paul	Minnesota
United States	Utah Gastroenternology - St. Mark's Office /ID# 163097	Salt Lake City	Utah
United States	Clinical Associates in Research Therapeutics of America, LLC /ID# 167954	San Antonio	Texas
United States	Southern Star Research Institute, LLC /ID# 169397	San Antonio	Texas
United States	Medical Assoc Research Grp /ID# 169149	San Diego	California
United States	San Diego Clinical Trials /ID# 212121	San Diego	California
United States	Univ of California San Francis /ID# 164583	San Francisco	California
United States	Guthrie Medical Group, PC /ID# 150533	Sayre	Pennsylvania
United States	The Polyclinic /ID# 165117	Seattle	Washington
United States	Virginia Mason Hospital & Medical Center /ID# 153030	Seattle	Washington
United States	Louisiana Research Center, LLC /ID# 150526	Shreveport	Louisiana
United States	Revival Research Institute, LLC /ID# 207281	Southfield	Michigan
United States	Penn State Health Colonnade /ID# 150267	State College	Pennsylvania
United States	Richmond University Medical Center /ID# 201860	Staten Island	New York
United States	Carl R. Meisner Medical Clinic /ID# 171270	Sugar Land	Texas
United States	Arizona Arthritis & Rheumatology Research, PLLC /ID# 169823	Sun City	Arizona
United States	Atlanta Gastroenterology Spec /ID# 150565	Suwanee	Georgia
United States	Clinical Research Trials of Florida, Inc. /ID# 201791	Tampa	Florida
United States	Duplicate_AdventHealth Tampa /ID# 200274	Tampa	Florida
United States	Duplicate_University of South Florida /ID# 214494	Tampa	Florida
United States	Baylor Scott & White Center for Diagnostic Medicine /ID# 204777	Temple	Texas
United States	Cotton O'Neil Clinical Research Center, Digestive Health /ID# 167183	Topeka	Kansas
United States	Adobe Clinical Research LLC /ID# 155249	Tucson	Arizona
United States	University of Arizona /ID# 150568	Tucson	Arizona
United States	Healthcare Research Consultant /ID# 163096	Tulsa	Oklahoma
United States	Options Health Research, LLC /ID# 150569	Tulsa	Oklahoma
United States	Tyler Research Institute, LLC /ID# 169147	Tyler	Texas
United States	Carle Foundation Hospital /ID# 151155	Urbana	Illinois
United States	The Vancouver Clinic, INC. PS /ID# 162334	Vancouver	Washington
United States	Gastro Health & Nutrition - Victoria /ID# 167764	Victoria	Texas
United States	Velocity Clinical Research - Salt Lake City /ID# 163180	West Jordan	Utah
United States	Western States Clinical Res /ID# 158078	Wheat Ridge	Colorado
United States	Atrium Health Wake Forest Baptist Medical Center /ID# 150528	Winston-Salem	North Carolina
United States	Clinical Trials of America /ID# 153453	Winston-Salem	North Carolina
United States	Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 157487	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belarus,  Belgium,  Bosnia and Herzegovina,  Brazil,  Canada,  Chile,  China,  Colombia,  Croatia,  Czechia,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Netherlands,  Norway,  Poland,  Portugal,  Puerto Rico,  Russian Federation,  Serbia,  Singapore,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing Treatment-Emergent Adverse Events	Treatment-emergent adverse events are defined as events that begin or worsen either on or after the first dose of the study drug and within 30 days after the last dose of the study drug in the analysis period.	Up to 288 Weeks

External Links

•   This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.